FDA Adverse Event
Malfunction
Summary report: N
APICAL HOLE PLUG
MDR report key: 1052089
·
Received May 20, 2008
Report
- Report Number
- 1825034-2008-00143
- Event Type
- Malfunction
- Date Received
- May 20, 2008
- Date of Event
- August 6, 2007
- Report Date
- August 9, 2007
- Manufacturer
- BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K070369
- Removal / Correction Number
- Z-102-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF WAREHOUSE AND RECOVERED INVENTORY FOUND APICAL PLUGS WERE NOT TO DESIGN SPECIFICATIONS. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED; EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATE. THIS REPORT FILED ON MAY 20, 2008.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING HIP PROCEDURE IN 2007, THE APICAL PLUG DID NOT FIT THE CUP SHELL PROPERLY, WOULD NOT ALLOW POLYETHYLENE LINER TO SEAT PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APICAL HOLE PLUG | LPH | BIOMET, INC. | NA | 522080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |